Methods and Devices for Alleviating Disorders Associated with Sinus Cavities

ABSTRACT

Generally, abnormal pressures in the sinus cavity can have physiological effects due to stimulation or injury of various nerves that are in proximity to the sinus, including increased or decreased pressure on the nerves as well as extrusion of the nerves into the sinus cavities due to bony dehiscence. Methods and devices for alleviating disorders associated with the sinus cavities are described. Embodiments herein include diagnosing these disorders by occluding or restricting the sinus ostium and assessing the physiological effects caused by the occlusion/restriction and treating these disorders by navigating/directing a dilating device to the sinus ostium and dilating the sinus ostium. Other embodiments are directed to devices for maintaining the ostial opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

The current application is a continuation of U.S. patent application No.17/157,821, entitled “Methods and Devices for Alleviating DisordersAssociated with Sinus Cavities” to Marc Richard Dean, filed Jan. 25,2021, which claims priority to U.S. Provisional Application No.62/965,294, entitled “Methods and Devices for Alleviating DisordersAssociated With the Sphenoid Sinus” to Marc Richard Dean, filed Jan. 24,2020, the disclosures of which are hereby incorporated by reference intheir entireties.

FIELD OF THE DISCLOSURE

The present disclosure relates to medical treatments, and in particularmethods and devices to alleviate disorders associated with sinuscavities, including the sphenoid sinus.

BACKGROUND OF THE DISCLOSURE

Many disorders and/or pathologies stem from issues with nervestimulation, such as understimulation and overstimulation of suchnerves, which can lead to various neuropathies and/or neuralgias. Thesepathologies include such things as optic neuropathy, autonomicdisfunction, trigeminal neuralgia, and migraines among many otherdisorders. Current methods of treating nerve disorders and pathologiesinvolve treating symptoms, such as pain. Further, these methodstypically rely on treating an individual with pharmaceutical orpharmacologic compositions. In many instances, pharmacologicaltreatments involve many complex issues caused by continual treatmentover long periods and/or reliance on an individual to carry thepharmaceuticals, should symptoms arise spontaneously. Additionally,these methods fall short of solving underlying physiological conditionsthat give rise to nerve pathologies in an individual.

SUMMARY OF THE DISCLOSURE

This summary is meant to provide examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the feature.

In one embodiment, a method for diagnosing chronic neurogenic sinusitisincludes manipulating pressure within a sinus cavity of an individual,and assessing physiological effects in the individual.

In another embodiment, the method further includes detecting nervesignals in the individual.

In a still further embodiment, the detecting nerve signals uses at leastone of the group consisting of: electromyography andelectrocardiography.

In still another embodiment, the method further includes restricting anostium of the sinus cavity by placing a restricting device in theostium.

In a yet further embodiment, the restricting device is selected from thegroup consisting of a plug, a balloon, and a dam.

In yet another embodiment, the restricting device allows for themanipulation of pressure within the sphenoid sinus.

In a further embodiment again, the sinus cavity is the sphenoid sinus.

In another embodiment again, manipulating the pressure is accomplishedusing a syringe, a vacuum, or a bulb.

In a further additional embodiment, the method further includesmeasuring the pressure within the sinus cavity.

In another additional embodiment, a method of treating chronicneurogenic sinusitis includes navigating a dilating device to a sinusostium of an individual and dilating the sinus ostium of the individual.

In a still yet further embodiment, the navigating step includesinserting a dilating device into a nostril and passing the dilatingdevice through the nasal cavity.

In still yet another embodiment, the dilating step is accomplished usingat least one of the following: calipers, a drill, a shaver, a piliatingpunch, a stanberger punch, thru-cut forceps, a balloon, and a sponge.

In a still further embodiment again, the navigating step is accomplishedusing an imaging technique.

In still another embodiment again, the imaging technique is selectedfrom at least one of the following: a camera, an endoscope, a telescope,and an image guided surgery system.

In a still further additional embodiment, the navigating step utilizesan image guided surgery system selected from the group consisting of:Johnson & Johnson TruDi, Medtronic Fusion, Medtronic Stealthstation 7,Medtronic Stealthstation 8, Stryker CranialMap, Stryker NAV3i, StrykerScopus Hybrid navigation, BrainLab ExacTrac, BrainLab Kick, BrainLabKickEM, BrainLab Curve, Fiagon Navigation System, ClaroNav Navient,ClaroNav Navident, Atracsys Sprytract 180, NDI Polaris Spectra, CollinDigipointur, Surgical Theater Surgical planner, EPED Iris-clinic, AnkeASA-610V, Micromar Aimnav, Bramsys BMS-225N, Synaptive BrightmatterGuide, and Heelforce Excelim-04.

In still another additional embodiment, the dilating step dilates thesphenoid ostium to a size of at least 3 mm.

In a yet further embodiment again, the method of treating chronicbaro-sinusitis further includes treating the sphenoid ostium.

In yet another embodiment again, the treating the sphenoid ostium stepincludes installing a stent in the sphenoid ostium.

In a yet further additional embodiment, the stent has a generallycylindrical frame defining an axial direction with openings on each end.

In yet another additional embodiment, the stent possesses a generallyhourglass shape, wherein the openings possess larger diameters than themiddle portion of the stent.

In a further additional embodiment again, the treating the sphenoidostium step includes topically applying a medicine to or within thesphenoid sinus.

In another additional embodiment again, the medicine is selected fromthe group consisting of: anti-inflammatories, anti-convulsants,antidepressants, stimulants, biologics, protective agents,nutraceuticals, anti-hypertensives, analgesics, anti-microbials, andanti-reflux compounds.

In various embodiments, the methods can be performed on a living animalor on a non-living cadaver, cadaver head, simulator (e.g. with the bodyparts, tissue, etc. being simulated), anthropomorphic ghost, etc.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates frontal and side views of sinuses in a human inaccordance with various embodiments.

FIG. 2 illustrates a cross-sectional view of a human nasal cavity andsphenoid sinus in accordance with various embodiments.

FIGS. 3A-3B illustrate cross-sectional views of the sphenoid sinus andsphenopalatine ganglion in relation to cranial anatomy in accordancewith various embodiments.

FIGS. 4A-4D illustrate representations of medical imaging of sphenoidsinuses with normal and abnormal anatomies in accordance with variousembodiments.

FIG. 5 illustrates a flow chart for a method of diagnosing chronicbaro-sinusitis in accordance with various embodiments.

FIG. 6 illustrates a flow chart for a method of treating chronicbaro-sinusitis in accordance with various embodiments.

DETAILED DESCRIPTION OF THE DISCLOSURE

Turning now to the diagrams and figures, embodiments herein are directedto methods of diagnosing and/or treating migraines and other disordersassociated with the sphenoid sinus. Some embodiments described hereinare designed to alleviate issues with the sphenoid sinus throughminimally invasive methods. Additional embodiments are directed todevices that can be implanted in the sphenoid sinus and/or the sphenoidsinus. Further embodiments are directed to methods to diagnose disordersassociated with the sphenoid sinus.

Turning to FIG. 1 , the sphenoid sinus is one of several sinuses thatexist in the cranium of an individual, including the ethmoid sinuses,maxillary sinuses, and frontal sinuses. As seen in FIG. 2 , the sphenoidsinus possesses an ostium that is typically medial to the superiorturbinate, which allows for pressure regulation and ventilation of thesphenoid sinus. As individuals age, the sphenoid sinus pneumatizes. (SeeScuderi et al., Amer. J. of Roentgenology, vol. 160, pp. 1101-04(1993).) On average, the sphenoid ostium in humans is approximately 4 mmin diameter; however, many individuals possess ostia with openingsapproximately 1 mm or less. In some instances, individuals may possessostia that are completely opacified or occluded (e.g., approximately 0mm opening).

Turning to FIGS. 3A-3B, the sphenoid sinus 302 is surrounded by one ofthe largest collections of nerves, including the sphenopalatine ganglion304 (also known as the pterygopalatine ganglion). Additionally, thesphenoid sinus is associated with the entirety or parts of thetrigeminal nerve, vidian nerve; the optical nerve; cranial nerves II,III, IV, V, and VI; direct fibers from cranial nerves II-VII, IX, and X,as well as nerves associated with the autonomic and parasympatheticpathways. As illustrated in FIG. 3B, the pneumatization (e.g.,hyperpneumatization) of the sphenoid sinus 302 in some individuals leadsto some of the nerves, such as sphenopalatine ganglion 304 being locatedor exposed within the sphenoid sinus 302, thus allowing for injuryand/or stimulation of these nerves. Stimulation of these nerves canresult in physiological consequences, including pain (e.g., neuralgia);sensory effects, such as changes in vision, ability to smell, balance,etc.; and/or migraines. In some instances, exposure of the nerves cancause the nerves to be affected by pathologies affecting the sphenoidsinus 302, such as infections or inflammation.

Turning to FIGS. 4A-4D, various exemplary representations of a sphenoidsinus are illustrated based on computerized tomography (CT) scans ofindividuals. FIG. 4A illustrates a coronal view of the sphenoid sinuses402, 402′ of an individual. While both sinuses show increasedpneumatization, the left sphenoid sinus 402′ (left in relation topatient's anatomy, right on figure) possesses a much higher level ofpneumatization causing an increase in volume of the left sphenoid sinus402′. Additionally, thinning of bone surrounding the left sphenoid sinus402′ leads to exposure of underlying nerves, including exposure of thevidian nerve 404, maxillary branch of trigeminal nerve 406, as well as aregion 408 including CN III, CN IV, CN VI, ophthalmic branch Vi, and aregion 410 containing the carotid artery. In contrast, the left sphenoidsinus 402 possesses no such thinning of the bone, thus possessing noexposed nerves or blood vessels.

FIGS. 4B and 4C illustrate a sagittal view of maxillary sinus 402, whereFIG. 4B illustrates an anatomically normal maxillary sinus, while FIG.4C illustrates sinuses with thinning of the bone, leading to exposure ofthe sphenopalatine ganglion 404 and maxillary branch of trigeminal nerve406, which are not exposed in an anatomically normal sinus of FIG. 4B.

FIG. 4D illustrates a coronal view of the frontal sinuses 402, 402′ ofan individual. Due to pneumatization of the right frontal sinus 402′,the ophthalmic branch of the trigeminal nerve 404 is exposed.

Besides anatomical variants, variations, or abnormalities with the sinuscavities, certain individuals may have abnormalities with the sinusostium, such as a smaller than usual ostium, either congenital oracquired. A smaller ostium can prevent pressure normalization andventilation within the sinus, thus creating an irregular pressure (e.g.,different from the anatomical normal pressure) within the sinus.Additionally, the ostium of some individuals can become restrictedand/or occluded, thus preventing pressure normalization and ventilationwithin the sinus. An increased pressure in the sinus places additionalpressure on the nerves, while a decreased pressure can cause a vacuumsurrounding one or more nerves into the sinus. In both increased anddecreased pressure situations, the nerves can be stimulated, andpotentially injured leading to one of the physiological conditions asnoted above, including pain. Such pressure issues can be considered asneurogenic sinusitis and/or baro-sinusitis. Such conditions may be acuteor chronic.

Identifying Chronic Neurogenic Sinusitis

Diagnosing chronic neurogenic sinusitis includes identifying individualsprone to irregular pressures in the sinus based on anatomical structure,including sinus pneumatization and/or ostium size. Diagnostic methods ofsome embodiments will identify individuals prone to chronic neurogenicsinusitis based on medical imaging of the sinus. Imaging methods thatcan be used in some embodiments include MRI, CT, PET, X-ray, and/or anyother applicable medical imaging technique. In various embodiments, theresulting image is assessed for specific anatomical variations and/orabnormalities that indicate chronic neurogenic sinusitis. Some of thephenomena indicative of chronic neurogenic sinusitis include size of thesinus to identify the extent of pneumatization, where overly pneumatizedsinuses can indicate the increased possibility of exposed nerves; bonedehiscence over nerve channels (e.g., foramen and/or fissures), whichcan expose the nerves and make the nerves susceptible to stimulation,injury, inflammation, and/or irritation; and/or any other anatomicalphenomenon due to exposure of the nerves. Further embodiments identifyother anatomical features, including the size of the ostium, such that asmaller ostium (caused by being boney or inflamed) indicating occlusionor an increased risk of occlusion, thus increasing the possibility ofcreating an abnormal pressure in the sphenoid sinus; and/or the sizeand/or location of the superior concha bullosa or supreme turbinate,which may occlude the ostium or increase the chance of occlusion fromforeign objects and/or inflammation. Numerous embodiments image thenerves in and/or surrounding the sinus to identify the likelihood ofexposure of these nerves to the sinus and/or dehiscence of the nervesinto the sinus.

Additional embodiments of diagnostic imaging methods integratealgorithms, including artificial intelligence and/or machine learningtechniques to automatically identify or detect the anatomical featuresof an individual, including the affected sinus, ostium, and/or anynerves present in the medical image. Additional embodiments determinethe size and/or pneumatization of these anatomical features. Furtherembodiments calculate a risk and/or identify a diagnosis for theindividual based on the anatomical features identified in the medicalimage. Various embodiments include more than one of the functions listedabove, such that some embodiments identify and determine the size ofanatomical features, while others will determine the size and assess arisk or determine a diagnosis for an individual. Several embodimentsidentify and determine the size of anatomical features and furtherassess a risk or determine a diagnosis for an individual.

Manual Methods of Diagnosing Chronic Neurogenic Sinusitis

Additional embodiments of directed to methods of diagnosing and/orconfirming chronic neurogenic sinusitis in an individual, such as ananimal, human, cadaver, cadaver head, anthropomorphic ghost, and/orsimulation/simulator. Turning to FIG. 5 , method 500 illustratesfeatures that can be used in such a diagnostic procedure. Additionally,while much of the discussion regarding FIG. 5 regards the sphenoidsinus, additional embodiments perform these methods on other sinuscavities throughout the head and body of an individual, including thefrontal and maxillary sinus cavities. Given the teachings set forthherein, one of skill in the art would understand how to navigate toother sinus cavities and ostia. Additional embodiments directed to theseother cavities also include additional methods to navigate to ostia asappropriate for a particular sinus.

In some of these embodiments, nerve signals are detected at 502. Certainembodiments detect nerve signals via neuromonitoring, such aselectromyography (EMG), electrocardiography (ECG), and/or any othersuitable method for neuromonitoring. At 502, one or more sensors (e.g.,electrodes) are placed in a subject at locations relevant to the areasexhibiting pain or other physiological symptom or areas that are tied toone or more of the nerves located in the vicinity of the sphenoid sinusor order to assess nerve signal propagation stemming from a stimulus inthe sphenoid sinus.

In many embodiments, the sphenoid ostium of a subject is artificiallyrestricted at 404. A number of embodiments will restrict the ostiumpartially (e.g., allowing some of the ostium to remain open), whileadditional embodiments completely restrict (e.g., fully occlude) theostium. In some embodiments, the restricting is accomplished by placinga restricting device, such as a plug, a balloon, a dam, a piece ofcotton, or another obstruction placed in the ostium to prevent orrestrict the pressure from normalizing within the sphenoid sinus. Incertain embodiments, the restricting device allows for the manipulationof pressure within the sphenoid sinus using a syringe, a vacuum, a bulband/or any other device capable of adding or removing a fluid, such asoxygen, nitrogen, air, or any other liquid or gas suitable for thispurpose. Additional embodiments include a pressure gauge, vacuum gauge,or other instrument for measuring pressure in a system.

At 506, the pressure of the sphenoid sinus is manipulated in variousembodiments. In some embodiments, the pressure is manipulated byallowing a restricting device or an occlusion to remain in place overtime. When occluded, the pressure within the sphenoid sinus of manyindividuals will naturally begin to decrease, creating a negativepressure within the sphenoid sinus, or increase, creating a positivepressure within the sphenoid sinus. While in many embodiments, anindividual, such as a doctor, manipulates the pressure using a syringe,a vacuum, a bulb and/or any other device capable of adding or removing afluid, such as oxygen, nitrogen, air, or any other fluid (e.g., liquidor gas) suitable for augmenting pressure. In some embodiments, thepressure is reduced in the sphenoid sinus by removing some of thenaturally occurring gas in the sphenoid sinus. In other embodiments,pressure is increased in the sphenoid sinus by adding a volume of afluid, such as the fluids mentioned above, into the sphenoid sinus. Incertain embodiments a doctor will augment the pressure in the sphenoidsinus by increasing then decreasing, or decreasing then increasing,pressure in the sphenoid sinus to test for the consequences of bothincreased and decreased pressure. In certain embodiments, themanipulation of pressure is accomplished by opening the sinus, such asby dilating an ostium or creating a new opening that normalizes pressurewithin the sinus and ambient or atmospheric pressure.

The pressure within the sphenoid sinus is measured at 508 of certainembodiments. At 508, an individual, such as a doctor or nurse, measuresthe pressure within the sphenoid sinus. The measurement can be obtainedusing a pressure gauge, vacuum gauge, or other instrument for measuringpressure in a system.

At 510 of many embodiments, physiological effects are assessed. Invarious embodiments, the physiological effects are assessed by queryinga subject as to any feelings or issues they are feeling after occlusionof the ostium and/or manipulated pressure in the sphenoid sinus. Incertain embodiments, EMG readings are measured from the electrodes, ifEMG electrodes have been placed in an individual. Further embodimentsactively stimulate one or more of the nerves in and/or exposed to thesphenoid sinus.

At 512, various embodiments identify drug levels or biomarkers presentin the blood or other bodily fluid of the individual. Such drug levelsinclude titer levels of analgesics, anti-inflammatories drugs (e.g.,Non-steroidal anti-inflammatory drugs, opioids, steroidalanti-inflammatories), or any other drug level to control pain, pressure,inflammation, and/or any other symptom that may be associated with anerve pain/issues or nervous system disorders. Biomarker levels includeany native molecule that is associated with pain/issues or nervoussystem disorders, including calcitonin gene related peptide (CGRP)levels.

In certain embodiments, chronic neurogenic sinusitis is diagnosed at514. In certain embodiments, physiological symptoms, including painand/or nerve stimulation tied to an augmented or decreased pressure inthe sphenoid sinus is assessed at this step. In many embodiments, thepresence of pain or nerve stimulation is indicative of one or moreexposed and/or dehiscent nerves in the sphenoid sinus that aresusceptible to pressure changes in the sphenoid sinus. In suchcircumstances, chronic neurogenic sinusitis is identified as a cause ofthe symptoms in a subject. In certain embodiments, an individual, suchas a doctor, may direct treatment for chronic neurogenic sinusitisthrough traditional methods or methods as described herein.Additionally, by identifying which nerves are affected by chronicbaro-sinusitis allows a medical practitioner the ability to predictand/or treat specific nerves and/or auras that may be associated with amigraine. Additional embodiments utilize the levels of drugs and/orbiomarkers present in blood or other bodily fluid to help form adiagnosis, where the inclusion of a drug may cause a dampening ofparticular symptoms, while the presence of certain biomarkers mayindicate an increased likelihood of certain conditions, including nervedisorders, including possible nervous system disorders and/or migraines.

The above features of the flow diagram of FIG. 5 may be executed orperformed in an order or sequence beside the order and sequence shownand described in FIG. 6 . Some of the above features of the flow diagramof FIG. 5 may be executed or performed substantially simultaneouslywhere appropriate. Additionally, in some embodiments, some of the abovefeatures of the flow diagram of FIG. 5 may be omitted.

Treating Sinus Pathologies

To resolve acute or chronic neurogenic sinusitis (or baro-sinusitis) inmany individuals, many embodiments dilate the sphenoid ostium to allowadequate pressure regulation in the sphenoid sinus in an individual,such as an animal, human, cadaver, cadaver head, anthropomorphic ghost,and/or simulation/simulator. Turning to FIG. 6 , many embodiments aredirected to minimally invasive methods to dilate a sinus ostium, such asmethod 600. Additionally, while much of the discussion regarding FIG. 6regards the sphenoid sinus, additional embodiments perform these methodson other sinus cavities throughout the head and body of an individual,including the frontal and maxillary sinus cavities. Given the teachingsset forth herein, one of skill in the art would understand how tonavigate to other sinus cavities and ostia. Additional embodimentsdirected to these other cavities also include additional methods tonavigate to and/or dilate ostia, including trephine, Caldwell-Luc, andany other procedures as appropriate for a particular sinus. Furthermore,the size to which a particular ostium is dilated for a particular sinuscavity may differ based on the particular sinus cavity, propensity oftissue in that area to heal, propensity of mucosal inflammation orinfection, or other factors that may warrant larger or smaller dilationsfor a particular sinus than provided for the sphenoid sinus.

Several embodiments navigate an observation device to the sphenoidostium at 602. In many embodiments, navigation involves inserting theobservation device into the nostril and passing the dilating devicethrough the nasal cavity (e.g., past the inferior, middle, and superiorturbinates) to the sphenoid ostium. In certain embodiments, theobservation device is inserted through the mouth and navigated into thenasal cavity through the connection in the throat. An observation devicein accordance with some embodiments is used to observe and/or measurethe ostium to identify an occluded or obstructed ostium and/or measurethe ostial opening. In certain embodiments, the observation device iscapable of imaging the sphenoid ostium and providing images (e.g.,photographs and/or video) to a medical practitioner, such as aphysician. In some embodiments, the images are live and/or real timeimages of the sphenoid ostium, while some embodiments obtain imagesand/or video to be viewed at a later time (e.g., stored for laterviewing).

At 604, many embodiments navigate a dilating device to the sphenoidostium. In numerous embodiments, the navigation step involves insertingthe dilating device in the same or a similar manner as the observationdevice as described above regarding an observation device. In certainembodiments, the dilating device is attached to a catheter or otherdelivery device capable of navigating through the nasal cavity. Someembodiments utilize one or more imaging techniques to aid in navigatingthe dilating device to the sphenoid ostium, such as a camera on thedelivery device, an endoscope, a telescope, an image guided surgerysystem (IGS) (optical and/or electromagnetic), such as Johnson &Johnson's TruDi system; Medtronic's Fusion or Stealthstation systems(e.g., Stealthstation 7, Stealthstation 8, etc.), Stryker's CranialMap,Scopus Hybrid navigation, or NAV3i; or BrainLab's ExacTrac, Kick,KickEM, or Curve systems; Fiagon's Navigation System; ClaroNav's Navientor Navident systems; Atracsys' Sprytract 180; NDI's Polaris Spectra;Collin's Digipointur; Surgical Theater's Surgical planner; EPED'sIris-clinic; Anke's ASA-610V; Micromar's Aimnav; Bramsys' BMS-225N;Synaptive's Brightmatter Guide; and/or Heelforce's Excelim-04.

In many embodiments, the dilating device is selected from one or more ofthe following: calipers, a drill, a shaver, a piliating punch, astanberger punch, thru-cut forceps, a balloon, a sponge, and/or anyother device capable of cutting or expanding a hole in the sphenoidostium.

Once the dilating device is located at the sphenoid sinus ostium, thesphenoid ostium is dilated in accordance to the type of dilating devicein many embodiments. For example, when using a drill, the drill bit isinserted through the ostium while spinning to allow the ostium toincrease in size as the drill bit pass through the ostium. Additionally,a punch is pushed through tissue (e.g., bone, mucosa, etc.) to expandostial size in embodiments using a punch. In embodiments using aballoon, the balloon is inserted through the ostium in a deflated state,then the balloon is inflated, thus expanding the size of the sphenoidostium. It should be noted that the above examples are only exemplary,and a qualified medical professional will understand the best techniquesof use for the specific dilating device being used to expand the ostium.

Additionally, in many embodiments, the sphenoid ostium is dilated to asize sufficient to allow pressure normalization of the sphenoid sinusand/or prevent occlusion of the sphenoid ostium at 606. In someembodiments, the sphenoid ostium is dilated to the typical average sizeof approximately 4 mm (±0.5 mm), while some embodiments dilate theostium to a size sufficient to allow pressure normalization within thesphenoid sinus. As such, certain embodiments dilate the ostium toapproximately 3 mm, 4 mm, 5 mm, 6 mm, or greater. Certain embodimentsdilate the ostium to a size approximately double the intended ostiumsize in case swelling, inflammation, scar tissue formation, or any otherphenomenon that may occlude or obstruct the ostium post dilation. Forexample, if 4 mm is the desired or intended size, the ostium is dilatedto approximately 8 mm to allow the ostium to remain at leastapproximately 4 mm after healing. As such, certain embodiments dilatethe ostium to approximately, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, orgreater.

In some embodiments, the time and/or pressure of the dilation step isaltered to provide histological benefit, when using a balloon or similardilating device. For example, dilating the ostium with a balloon for aperiod of time and at a particular pressure may help stabilize themucosa within the ostium and/or prevent further inflammation of themucosa in the future. In some embodiments, the dilating step inflates aballoon for up to about 10 minutes (±1 minute) before releasing pressurefrom the balloon. Specifically, certain embodiments maintain the ballooninflated for about 1 minute, about 2 minutes, about 3 minutes, about 4minutes, about 5 minutes, about 6 minutes, about 7 minutes, about 8minutes, about 9 minutes, or about 10 minutes. Additionally, severalembodiments inflate the balloon to a pressure of up to about 15atmospheres (atm) (±1 atm), depending on efficacy or need of a pressureto dilate or maintain dilation. Specifically, certain embodimentsinflate the balloon to about 5 atm, about 6 atm, about 7 atm, about 8atm, about 9 atm, about 10 atm, about 11 atm, about 12 atm, about 13atm, about 14 atm, or about 15 atm. In combination, embodiments utilizedifferent combinations of time and pressure to achieve the desiredresults. For example, if a 2-minute inflation at 12 atm is shown to showthe desired results, some embodiments may inflate to a lower pressurefor a longer time to achieve similar results (e.g., 10 atm for 3minutes).

Further embodiments treat the sphenoid ostium to maintain the ostialopening at 608. In certain embodiments, a mechanical device, such as astent, is used to prevent an ostium from closing such as from a healingprocess or formation of scar tissue. In certain embodiments, a topicalapplication of a medicine is used to treat the tissue in the ostium toprevent inflammation and/or tissue growth, which may obstruct or occludethe ostium after dilation. For example, anti-inflammatories (e.g.,steroids, NSAIDs), anti-convulsants (e.g., gabapentin, sumatriptan),antidepressants (e.g., SSRIs); stimulants (e.g., caffeine, epinephrine);biologics, including anti-CGRP drugs (e.g., Aimovig, Ajovy, Emgality,and Dupixent); protective agents (e.g., Carafate, petroleum jelly),nutraceuticals, (e.g., curcumin, willow bark extract, CBD),anti-hypertensives (e.g., alpha- and beta-blockers, calcium channelblockers), analgesics (e.g., lidocaine, benzocaine), anti-microbials(e.g., antibiotics, antivirals, antifungals), anti-reflux compounds(e.g., PPIs, H₂ blockers) and/or any other drug producing the desiredeffect, or a combination thereof can be applied to the dilated ostium toprevent closure of the ostium. In certain embodiments, the drug isapplied to the dilating device directly, such that 608 occurssimultaneously with 606.

A stent in accordance with some embodiments forms a generallycylindrical frame defining an axial direction with openings on each end.In some embodiments, the stent is collapsible and expandable fordelivery using a balloon catheter or encapsulated within a sheathcatheter. In other embodiments, the stent is rigid and is inserted intoan ostium. In numerous embodiments, the stent is made of a biocompatiblematerial. In some embodiments the frame is a suitably long enough suchthat one opening is in the sphenoid sinus, while the other end remainsin the nasal cavity. In numerous embodiments, the diameter of the stentmatches the size of the ostium, such that the diameter is approximately3 mm, 4 mm, 5 mm, 6 mm, or greater. In some embodiments, the diameter ofthe stent may exceed the size of the ostium in order to secure the stentin the ostium.

The stent of many embodiments is constructed of a stable andbiocompatible material for permanent installation, or planned removal inthe future after installation, such as some metals and/or plastics. Forexample, the stent can be manufactured from one or more of the followingmaterials: stainless steel, a nickel-based alloy (e.g., acobalt-chromium or a nickel-cobalt-chromium alloy), Nitinol, certainpolymers, any other biocompatible material, and/or combinations thereof.

In several embodiments, the stent is constructed of a bioabsorbable orbiodegradable material, such that the stent will eventually break downand not remain as a foreign body in an individual. Examples ofbioabsorbable materials include poly(L-lactide) (PLLA), poly(D-lactide)(PDLA), polyglycolide (PGA), poly(L-lactide-co-glycolide) (PLGA),polyhydroxyalkonate (PHA), polysaccharides, proteins, polyesters,polyhydroxyalkanoates, polyalkelene esters, polyamides,polycaprolactone, polylactide-co-polycaprolactone, polyvinyl esters,polyamide esters, polyvinyl alcohols, modified derivatives ofcaprolactone polymers, polytrimethylene carbonate, polyacrylates,polyethylene glycol, hydrogels, photo-curable hydrogels, terminal dials,poly (L-lactide-co-trimethylene carbonate), polyhydroxybutyrate;polyhydroxyvalerate, poly orthoesters, poly anhydrides, polyimmocarbonates, and copolymers and combinations thereof.

Further embodiments of stents also have elements of maintaining theposition in the sphenoid ostium. Some embodiments possessing theseelements will include tissue engaging elements capable to allow fixationof the stent to the wall of the sphenoid ostium. The tissue engagingelements can be any number of shapes, including barbs, coils, and/orarrowheads. Numerous embodiments may shape the stent into an hourglassshape that the openings possess larger diameters than the middle portionof the stent. In this configuration, the larger diameters of theopenings will prevent the stent from moving into or out of the sphenoidostium.

It should be noted that embodiments may possess one or more of the abovefeatures, such as certain embodiments may possess more than one of anhourglass shape, tissue engaging elements, and/or constructed of variousbiocompatible materials.

Additionally, certain embodiments involving a stent will further includea drug impregnated into the stent, such as the drugs described above toprevent closing of the ostium. Including a drug impregnated with thestent can allow for a controlled release of the drug over time, or itcould be a fast-acting drug to be applied for only temporary applicationto the ostium.

At 610, many embodiments will treat to the interior of the sphenoidsinus to alleviate pain or other consequences from nerve stimulation dueto chronic baro-sinusitis. In certain embodiments, the treatment is aphysical (e.g., non-drug) treatment method, while additional embodimentswill apply a drug to the interior of the sphenoid sinus. Someembodiments utilize a combination of physical and drug-based treatmentsto the interior of the sphenoid sinus. In many embodiments, thetreatment will be temporary to alleviate symptoms without long termeffects, while some embodiments utilize permanent methods to alleviatesymptoms. In a number of embodiments, the treatment utilizes bothtemporary and permanent treatments to alleviate symptoms, such as topermanently block stimulation of some nerves but only temporarily blockstimulation of certain nerves.

Physical methods include ablation, irreversible electrophoresis (IRE),light therapy, targeted radiation, signal modulation, stimulating anerve in a reflex arc to prevent stimulation of an overstimulated nerve,increasing the stimulation of an understimulated or non-stimulatednerve, or stimulating a nerve that is understimulated due to damage orother pathology. Drug-based methods include the application of one ormore of an anti-inflammatory (e.g., steroids, NSAIDs), ananti-convulsant (e.g., gabapentin, sumatriptan), an antidepressant(e.g., SSRIs); a stimulant (e.g., caffeine, epinephrine); a biologic,including an anti-CGRP, (e.g., Aimovig, Ajovy, Emgality, and Dupixent);a protective agent (e.g., Carafate, petroleum jelly), a nutraceutical,(e.g., curcumin, willow bark extract, CBD), an anti-hypertensive (e.g.,alpha- and beta-blockers, calcium channel blockers), an analgesic (e.g.,lidocaine, benzocaine), an anti-microbial (e.g., antibiotics,antivirals, antifungals), an anti-reflux compound (e.g., PPIs, H₂blockers) and/or any other drug producing the desired effect, or acombination thereof. In many embodiments, drug treatments are topicallyapplied to the nerve. Topically treating the nerve directly provides thebenefits of direct targeting of the nerve of issue, which can allowlower doses of the drug as well as fewer systemic side effects caused bytraditional methods of oral, intravenous, or any other method oftreating symptoms using some drugs. Furthermore, various embodimentsapply the drug via a balloon or other drug reservoir to allow fortopical and regulated release of the drug.

The above features of the flow diagram of FIG. 6 may be executed orperformed in an order or sequence beside the order and sequence shownand described in FIG. 6 . Some of the above features of the flow diagramof FIG. 6 may be executed or performed substantially simultaneouslywhere appropriate—for example, some embodiments may utilize acombination observation and dilation device, where the ostium is imagedfollowed immediately by dilation and/or treatment without a secondnavigation step. Additionally, in some embodiments, some of the abovefeatures of the flow diagram of FIG. 6 may be omitted.

Treating Additional Disorders

It should be noted that the above example to treat chronic neurogenicsinusitis is only one disorder, and these embodiments of these devicesand methods can also be used to treat other, similar phenomena in anindividual. For example, nerves in the ear (including the facial,vestibular, and cochlear nerves) may also be associated with pain orother physiological effect caused by abnormal pressures in the middleear cavities. As such, some embodiments are directed to modifying theEustachian tube to allow improved pressure normalization and/orregulation in the middle ear to alleviate pressure on the dura, cochlea,semicircular canals, carotid artery, round window, facial nerve, nervusintermedius, geniculate ganglion, Jacobson's nerve, Arnold's nerve,nerve to the stapedius, tympanic plexus, erichlear branch of thetrigeminal nerve, and/or chorda tympani. It should be noted that adoctor or physician would be knowledgeable how to adjust the methodsdescribed above to allow for pressure regulation and/or normalizationwithin the ear.

Additionally, other pneumatized cavities throughout the body, including(but not limited to) pneumatized cavities in the head, including themaxillary, frontal, and ethmoid sinuses, as well as concha bullosa, mayalso be associated with nerves and pain or other physiological effectassociated with abnormal pressures in those sinuses. Several embodimentsherein are directed to dilating or creating ostia or other openings inthese other sinuses to regulate and/or normalize pressures within thesesinuses. A physician or other medical professional will be able tomodify techniques and embodiments described above to obviate oralleviate physiological effects associated with the abnormal pressureswithin these other sinuses, including the use of certain gascompositions (e.g., oxygen, nitrogen, heliox, air, etc.).

Doctrine of Equivalents

While the above description contains many specific embodiments of theinvention, these should not be construed as limitations on the scope ofthe invention, but rather as an example of one embodiment thereof.Accordingly, the scope of the invention should be determined not by theembodiments illustrated, but by the appended claims and theirequivalents.

1-22. (canceled)
 23. A method for diagnosing chronic neurogenicsinusitis comprising: obtaining a medical image of an individual,wherein the medical image comprises an image of a sinus cavity;identifying an anatomical feature within the sinus cavity, wherein theanatomical structure is selected from one or more of: pneumatization,ostium size, dehiscence, injury, remodeling, inflammation, andirritation; and identifying neurogenic sinusitis in the individual,wherein neurogenic sinusitis is characterized by anatomical featuresthat allow for stimulation of at least one nerve due to an abnormalbarometric pressure within the sinus cavity.
 24. The method of claim 23,wherein identifying an anatomical feature within the sinus cavityutilizes at least one of artificial intelligence and machine learning toidentify the anatomical feature.
 25. The method of claim 23, whereinidentifying an anatomical feature within the sinus cavity utilizes atleast one of artificial intelligence and machine learning to access theeffect and degree of pressure change within the sinus cavity.
 26. Themethod of claim 23, wherein the medical image is obtained by at leastone of the following: a camera, an endoscope, a telescope, MRI, CT, PET,X-ray and an image guided surgery system.
 27. The method of claim 23,wherein at least one of the anatomical features identified is the ostiumsize and wherein the effect of the ostium size and location on pressureand ventilation within the sinus cavity is calculated by a computerassisted algorithm.
 28. The method of claim 23, wherein at least one ofthe anatomical features identified is the ostium size and wherein anideal ostium size needed to normalize pressure and ventilation withinthe sinus cavity is determined by computer assisted algorithm.
 29. Themethod of claim 23, wherein identifying neurogenic sinusitis comprisesdetermining the size of at least one anatomical feature.
 30. The methodof claim 29, wherein determining the size of at least one anatomicalfeature comprises determining a pneumatization of the sinus cavity. 31.The method of claim 30, wherein determining the size of at least oneanatomical feature further comprises determining an ostium size of thesinus cavity.
 32. The method of claim 31, wherein identifying neurogenicsinusitis further comprises identifying a smaller than average ostiumand sinus cavity hyperpneumatization, wherein the smaller than averageostium increases a risk of abnormal pressure within the sinus cavity,and wherein hyperpneumatization of the sinus cavity increases a risk ofan exposed nerve susceptible to stimulation due to the abnormal pressurecaused by the smaller than average ostium.
 33. The method of claim 32,wherein the sinus cavity is selected from the sinus group consisting ofthe sphenoid, frontal, maxillary, and ethmoid.
 34. The method of claim32, wherein the exposed nerve is selected from: a trigeminal nerve, avidian nerve; an optical nerve; a cranial nerve II, a cranial nerve III,a cranial nerve IV, a cranial nerve V, a cranial nerve VI; a directfibers from cranial nerve II, a direct fibers from cranial nerve III, adirect fibers from cranial nerve IV, a direct fibers from cranial nerveV, a direct fibers from cranial nerve VI, a direct fibers from cranialnerve VII, a direct fibers from cranial nerve IX, a direct fibers fromcranial nerve X, and combinations thereof.
 35. The method of claim 31,wherein identifying neurogenic sinusitis comprises identifying anoccluded ostium and sinus cavity hyperpneumatization, wherein thesmaller than average ostium increases a risk of abnormal pressure withinthe sinus cavity, and wherein hyperpneumatization of the sinus cavityincreases a risk of an exposed nerve susceptible to stimulation due tothe abnormal pressure caused by the occluded ostium.
 36. The method ofclaim 35, wherein the sinus cavity is selected from the sinus groupconsisting of the sphenoid, frontal, maxillary, and ethmoid.
 37. Themethod of claim 36, wherein the exposed nerve is selected from: atrigeminal nerve, a vidian nerve; an optical nerve; a cranial nerve II,a cranial nerve III, a cranial nerve IV, a cranial nerve V, a cranialnerve VI; a direct fibers from cranial nerve II, a direct fibers fromcranial nerve III, a direct fibers from cranial nerve IV, a directfibers from cranial nerve V, a direct fibers from cranial nerve VI, adirect fibers from cranial nerve VII, a direct fibers from cranial nerveIX, a direct fibers from cranial nerve X, and combinations thereof 38.The method of claim 31, identifying neurogenic sinusitis comprisesmodeling sinus ventilation based on the size of the ostium andpneumatization of the sinus cavity, wherein subnormal ventilationprevents pressure normalization, and increases risk of abnormal pressurewithin the sinus cavity and increases a risk of an exposed nervesusceptible to stimulation due to the abnormal pressure.
 39. The methodof claim 23, further comprising: manipulating a barometric pressurewithin the sinus cavity of an individual, wherein manipulating thebarometric pressure comprises: occluding all ostia associated with thesinus cavity; and changing the barometric pressure within the sinuscavity; and assessing one or more of neuropathy and neuralgia of theindividual, wherein a change of severity of at least one of the one ormore of neuropathy and neuralgia due to the manipulated barometricpressure indicates the individual possesses neurogenic sinusitis. 40.The method of claim 23, further comprising: manipulating a change in abarometric pressure within the sinus cavity comprising: occluding atleast one ostia associated with the sinus cavity, and changing thebarometric pressure within the sinus cavity; and assessing one or moreof a neuropathy and a neuralgia of the individual, wherein a change ofseverity of at least one of the one or more of neuropathy and neuralgiadue to the manipulated barometric pressure indicates neurogenicsinusitis in the individual.
 41. The method of claim 40, whereinoccluding at least one ostia comprises placing a restricting device inall ostia associated with the sinus cavity.
 42. The method of claim 41,wherein the restricting device is selected from the group consisting ofa plug, a balloon, and a dam.
 43. The method of claim 40, whereinchanging the barometric pressure is accomplished using a syringe, avacuum, or a bulb.
 44. A method of treating chronic neurogenic sinusitiscomprising: obtaining a medical image of an individual, wherein themedical image comprises an image of a sinus cavity; identifying ananatomical feature within the sinus cavity, wherein the anatomicalstructure is selected from one or more of: pneumatization, ostium size,dehiscence, injury, inflammation, bony remodeling and irritation;identifying neurogenic sinusitis in the individual, wherein neurogenicsinusitis is characterized by anatomical features that allow forstimulation of at least one nerve due to an abnormal barometric pressurewithin the sinus cavity; and dilating the sinus ostium of the individualto at least 3 mm, wherein dilating the sinus ostium relieves theabnormal barometric pressure within the sinus cavity, wherein relievingthe abnormal barometric pressure within the sinus cavity alleviates atleast one of the one or more of neuropathy and neuralgia.
 45. The methodof claim 44, further comprising navigating a dilating device to thesinus ostium of an individual by: inserting a dilating device into anostril; and passing the dilating device through the nasal cavity. 46.The method of claim 44, wherein the medical image is obtained by atleast one of the following: a camera, an endoscope, a telescope, MRI,CT, PET, X-ray and an image guided surgery system.